Thermographic device for measurement of differential temperatures in tissue

Abstract

A thermographic sensing device for measuring temperatures at one or more regions of the human body, particularly the breast, utilizes a thermographic composition deposited into linear arrays of recesses formed in the lobes of a conformable medium which is disposable against the skin. The thermographic composition includes a binary solvent system and at least one colorant, wherein the compositions in each array are formulated to melt at precise temperatures, within a diagnostically temperature relevant range, to change from a first visible color to a second visible color.

What is claimed is: 
     
       1. A device for measuring temperatures at one or more regions on a human, the device comprising:
 a platform having a first surface and a second surface, wherein the platform is shaped to define a plurality of lobe areas wherein each of the plurality of the lobe areas is conformable to a shape of a human breast, and wherein a hole is defined at a center of the platform; 
 a temperature sensing module disposed on each lobe area of the first surface of the platform, the module comprising:
 a heat conducting substrate comprising metallic foil, the substrate having a top surface and a plurality of linear arrays, each array comprising a plurality of spaced apart recesses, defined in the top surface; 
 a protective layer of material disposed on the top surface of the heat conducting substrate; 
 a thermographic composition disposed in each recess; and 
 a transparent sealing layer disposed over the heat conducting substrate to seal each recess, 
 wherein the thermographic composition comprises:
 a binary solvent system comprising relative amounts of ortho-chloronitrobenzene (OCNB) and ortho-bromonitrobenzene (OBNB); 
 a first dye comprising crystal violet lactone which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition; 
 a second dye comprising (1-methylamino)anthraquinone which is present in an amount of 0.04% to 0.05% by weight, based on the total weight of the thermographic composition, or 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol which is present in an amount of 0.03% to 0.05% by weight, based on the total weight of the thermographic composition; and 
 an activator comprising bisphenol A and 2,2′, 4′4′-tetrahydroxybenzophenone, each of which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition, and wherein the activator also comprises arachidic acid in an amount of 0.01% to 0.03% by weight, based on the total weight of the thermographic composition; and 
 wherein the relative amounts of OCNB and OBNB determine a melting point of the thermographic composition, and wherein the linear array of spaced apart recesses are radially arranged with respect to the center of the platform, wherein the thermographic compositions in the recesses in any one linear array are identical and have the same melting point, and wherein the radial arrangement is in an order corresponding to sequentially increasing melting points of the thermographic compositions over a diagnostically relevant temperature range of about 88° F. to about 106.7° F., wherein a difference between respective melting points of the thermographic compositions in the recesses of adjacent linear arrays is in a range of 0.2° F. to 1.0° F. 
 wherein the thermographic composition, when in a solid state, exhibits a first color and, when in a liquid state, exhibits a second color, distinct from the first color, each of the first and second colors being visible to the naked eye. 
 
 
 
     
     
       2. The device of  claim 1 , wherein the temperature sensing module covers less than all of the first surface of the platform. 
     
     
       3. The device of  claim 1 , wherein alternate linear arrays of recesses have different numbers of recesses. 
     
     
       4. The device of  claim 3 , wherein the number of recesses in the linear arrays alternates between 7 and 15 recesses. 
     
     
       5. The device of  claim 3 , wherein the number of recesses in the linear arrays alternates between 8 and 14 recesses. 
     
     
       6. The device of  claim 1 , wherein the activator comprises an organic acid having a pK a  of about 4 to about 12. 
     
     
       7. The device of  claim 6 , wherein the organic acid is selected from the group consisting of phenol, bisphenol A, arachidic acid, pyrocathechol and 3-nitrophenol, and combinations of two or more thereof. 
     
     
       8. The device of  claim 1 , wherein the second dye is (1-methylamino)anthraquinone. 
     
     
       9. The device of  claim 1 , wherein the second dye is 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol. 
     
     
       10. The device of  claim 1 , further comprising
 a releasable cover layer, having a shape corresponding to the platform, provided over the device and releasably attached to the first surface of the platform by the adhesive at the periphery. 
 
     
     
       11. The device of  claim 1  in combination with a second device and instructional materials for using the device, wherein the device and second device and instructional materials are packaged as a kit. 
     
     
       12. The device of  claim 1  further comprising a readable data structure disposed on one of the first and second surfaces of the platform. 
     
     
       13. The device of  claim 1 , wherein the platform is shaped to define three lobe areas. 
     
     
       14. The device of  claim 1 , wherein the plurality of linear arrays of recesses comprises 18 linear arrays of recesses. 
     
     
       15. A method for comparatively detecting temperature differentials in the same regions of a biological anatomy comprises:
 A) obtaining plural similar thermographic temperature sensing devices, each device having a temperature sensing module comprising:
 a heat conducting substrate comprising metallic foil, the substrate having a top surface and a plurality of linear arrays comprising a plurality of spaced apart recesses defined in the top surface; 
 a protective layer of material disposed on the top surface of the heat conducting substrate; 
 a thermographic composition disposed in each recess the thermographic composition comprising:
 a binary solvent system comprising relative amounts of ortho-chloronitrobenzene (OCNB) and ortho-bromonitrobenzene (OBNB); 
 a first dye comprising crystal violet lactone which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition; 
 a second dye comprising (1-methylamino)anthraquinone which is present in an amount of 0.04% to 0.05% by weight, based on the total weight of the thermographic composition, or 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol which is present in an amount of 0.03% to 0.05% by weight, based on the total weight of the thermographic composition; and 
 an activator comprising bisphenol A and 2,2′, 4′4′-tetrahydroxybenzophenone, each of which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition, and wherein the activator also comprises arachidic acid in an amount of 0.01% to 0.03% by weight, based on the total weight of the thermographic composition; 
 
 wherein the relative amounts of OCNB and OBNB determine a melting point of the thermographic composition, and 
 wherein the thermographic composition, when in a solid state, exhibits a first color and, when in a liquid state, exhibits a second color, distinct from the first color, each of the first and second colors being visible to the naked eye; 
 
 B) simultaneously applying each thermographic temperature sensing devices to one of symmetrically similar regions of the biological anatomy for a time duration; and 
 C) comparing by visual inspection of the thermographic temperature sensing devices after the time duration of whether a difference in color of the recesses of the plurality of linear arrays exists between two of the sensing devices indicating a temperature differential between symmetrically similar regions of the biological anatomy. 
 
     
     
       16. The method of  claim 15 , wherein the thermographic compositions in the recesses in any one linear array are identical and have a same melting point within a diagnostically relevant temperature range. 
     
     
       17. The method of  claim 15 , wherein no two linear arrays contain thermographic compositions with the same melting point. 
     
     
       18. The method of  claim 15 , wherein the linear arrays are arranged in an order corresponding to sequentially increasing thermographic composition melting points. 
     
     
       19. The method of  claim 15 , wherein the different thermographic composition melting points in the plurality of linear arrays define the diagnostically relevant temperature range.